Job Overview:
This is an onsite position in one of our office locations.
Fully remote is not eligible.
Key Responsibilities:
* Lead the cross-functional study team responsible for clinical study delivery and provide operational input into protocol development.
* Oversee and provide input to the development of study specific documentation, including case report forms (CRF), data management plan, monitoring plan, etc.
* Ensure compliance with clinical trial registry requirements and identify outsourcing needs of the study.
* Provide input into baseline budget development and management, and lead risk assessment and identifies risk mitigation strategies at the study level.
* Lead the feasibility assessment to select relevant regions and countries for the study, oversee site evaluation and selection, and monitor progress for site activation and monitoring visits.
* Develop and implement patient recruitment and retention strategies, and ensure accurate scope changes for internal and external studies.
* Oversee the execution of the clinical study against planned timelines, deliverables, and budget, and ensure clinical project audit and inspection readiness through the study lifecycle.
Requirements:
* Exceptional interpersonal & leadership skills
* Advanced expertise and implements the operational strategic direction and guidance for respective clinical studies
* Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving
* Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
* Strong experience in budget management
* Ability to build, lead, and develop productive study teams and collaborations
* Advanced negotiation and interpersonal skills to vendor management
* Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents
What We Offer:
We have an inclusive and diverse culture that provides comprehensive benefits, which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.